University Hospitals of Cleveland

Company: University Hospitals of Cleveland
Product: Blood products
Date: 8/19/02

With respect to your response to FDA-483 item #2, you stated that you will institute a computer change. We expect that changes to the computer system should be validated. Please provide documentation of the validation for this new change. Additionally, please explain what actions and/or retraining were taken with this particular phlebotomist.

FDA District: Cincinnati District Office

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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